Status
Terminated
Drug Enforcement D-611-2013
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Classification
Class II
Report Date
July 3, 2013
Termination Date
July 17, 2015
Product Information
- Product description
- 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
- Product quantity
- 2,137,660 units
- Reason for recall
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-611-2013
- Event ID
- 61918
- Recall initiation date
- May 4, 2012
- Center classification date
- June 21, 2013
- Code info
- Lot #: a) 89-135-JT, 04-224-JT, 07-138-JT, Exp 4/13, 08-160-JT Exp. 8/13 ; b) 08-163-JT, 90-036-JT, 02-048-JT, Exp 2/13; c) 93-102-JT, 11-063-JT, Exp 9/12; d) 93-096-JT, Exp 11/12
- More code info
- —